Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase

This study has been completed.

Sponsor:

Collaborator:

Korean Health Technology R&D Project, Ministry of Health & Welfare

Information provided by (Responsible Party):

Yeon-Ho Joo, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT01455038

First received: October 18, 2011

Last updated: NA

Last verified: October 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 18, 2011
Last Updated Date	October 18, 2011
Start Date ^ICMJE	January 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 18, 2011)	Heart rate variability (HRV) [ Time Frame: at baseline ] [ Designated as safety issue: No ] Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN). Frequency domain - TP (The variance of NN intervals over the temporal segment), VLF(Power in very low frequency range; <0.04 Hz), LF(Power in low frequency range; 0.04~0.15 Hz), HF(Power in high frequency range; 0.15~0.4 Hz)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase
Official Title ^ICMJE	Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase
Brief Summary	The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.
Detailed Description
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Cross-Sectional
Biospecimen
Sampling Method	Non-Probability Sample
Study Population	Thirty three (10 males, 23 females) patients in clinically remitted state diagnosed with bipolar disorder based on DSM-IV criteria were enrolled at one outpatient psychiatric clinic and 59 healthy controls (23 males, 36 females) from health promotion center in a university-affiliated general hospital. We defined an individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale (MADRS) score of 10 or less and Clinical Global Impression severity (CGI-S) of 3 or less for last one month. Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.
Condition ^ICMJE	Bipolar Disorder Subsyndromal Depressive Phase Heart Rate Variability
Intervention ^ICMJE
Study Group/Cohort (s)	Control group Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist. Bipolar group individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale score of 10 or less and Clinical Global Impression severity of 3 or less for last one month.
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	92
Completion Date	April 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Bipolar group: DSM-IV bipolar disorder Montgomery-Åsberg depression rating scale (MADRS) score for last one month : ≤ 10 Clinical Global Impression severity (CGI-S) for last one month : ≤ 3 Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist. Exclusion Criteria: Psychiatric disorder except bipolar disorder Neurological symptoms or signs History of head trauma History of cardiovascular diseases Any medication except psychiatric medication.
Gender	Both
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01455038
Other Study ID Numbers ^ICMJE	A090116
Has Data Monitoring Committee
Responsible Party	Yeon-Ho Joo, Asan Medical Center
Study Sponsor ^ICMJE	Asan Medical Center
Collaborators ^ICMJE	Korean Health Technology R&D Project, Ministry of Health & Welfare
Investigators ^ICMJE
Information Provided By	Asan Medical Center
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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